trial comparing the effects of aripiprazole with those of standard of care on non-hdl cholesterol in patients with schizophrenia or bipolar i disorder who have metabolic syndrome

Conditions: Schizophrenia; Schizoaffective Disorder; Bipolar I Disorder; Metabolic Syndrome

Summary: the purpose of this study was to determine whether patients with schizophrenia, schizoaffective disorder, or bipolar i disorder who also have metabolic syndrome have a larger decrease in fasting non-high density lipoprotein (non-hdl) cholesterol levels with aripiprazole than with their current atypical antipsychotic treatment (olanzapine, risperidone, or quetiapine).


Eligibility criteria:
inclusion criteria: * competency in understanding nature of study and ability to sign informed consent form * a clinical diagnosis of schizophrenia, schizoaffective disorder, or bipolar i disorder (manic or mixed) that has been treated with antipsychotics (oral olanzapine, risperidone or quetiapine) for at least 3 months. * treatment with any of the antipsychotic medications olanzapine, risperidone, or quetiapine for at least 3 months * a clinical global impression-severity scale score of 4 or lower at baseline * confirmed diagnosis of metabolic syndrome * patients not receiving treatment specifically for any of the parameters related to metabolic syndrome at the time of randomization * women of childbearing potential must be using an adequate method of contraception to avoid pregnancy throughout the study and up to 4 weeks after last dose of investigational product * patients for whom it is clinically appropriate to switch from their current atypical antipsychotic to aripiprazole (determined by the investigator) exclusion criteria: * risk of suicide (suicidal ideation or recently attempted suicide) * meeting diagnostic and statistical manual of mental disorders, 4th ed, text revision criteria for any significant psychoactive substance use disorder within 3 months of screening * diagnosis of type 1 or 2 diabetes mellitus * current treatment for 1 of the components of metabolic syndrome * use of medication for the purpose of weight loss * diagnosis of bipolar disorders other than bipolar 1, depression with psychotic symptoms, or organic brain syndromes * history of neuroleptic malignant syndrome * diagnosis of parkinson's disease, alzheimer's disease, multiple sclerosis, cerebral palsy, epilepsy, or mental retardation * history of seizures * abnormal blood count for platelets, hemoglobin, absolute neutrophils, aspartate aminotransferase, alanine aminotransferase, creatinine, fasting glucose, and thyroid-stimulating hormone * electrocardiogram recording with qtc interval \>475 msec * detectable levels of cocaine or positive screen for stimulants or other drugs considered (determined by the investigator) to be of abuse or dependence * blood alcohol levels superior or equal to 50 mg/dl \[or 10.9 mmol/l\] * prior participation in an aripiprazole clinical trial * treatment with aripiprazole within 1 month of enrollment * predefined exclusionary laboratory tests * patients with bipolar disorder treated with adjunctive therapy other than a stable dose of mood stabilizers (lithium or valproate) must undergo a 30-day washout period for adjunctive therapies, such as antidepressants, prior to randomization.